# K973261: Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: Nov 24, 1997 after 87 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. Rheumatoid arthritis Correction of functional deformity Revision procedures where other treatments or devices have failed. Treatment of non-unions, femoral neck, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K973261
Methodology: https://510kreport.com/methodology